MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRX HUM LO PLT LT 4H 83MM; TRAUMA IMPLANT

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

Event Date 12/17/2021

Event Type  Injury  

Event Description

It was reported in a study that one of the locking screws was pulled out.The patient was enrolled as subject in a study and when he visited the hospital for his three month follow-up visit where screw removal was found.The pulled screw came out through the skin and the patient manually removed it by himself.The patient had moderate pain and after the removal of screw, the pain was relieved.Attempts have been made and there is no further information at this time.

Manufacturer Narrative

(b)(4).Date of birth: (b)(6).Medical product: catalog #: 110030101, prx hum lo plt lt 4h 83mm, lot # rm901p.Catalog #: 816140034, 4.0mm canc lock screw 34mm, lot # unknown.Catalog #: 816140042, 4.0mm canc lock screw 42mm, lot # unknown.Catalog #: 816140040, 4.0mm canc lock scrw 40mm, lot # unknown qty.2 catalog #: 816140042, 4.0mm canc lock screw 42mm, lot # unknown.Catalog #: 110018054, screw t15 md 3.5x54mm ns, lot # unknown.Catalog #: 110018056, screw t15 md 3.5x56mm ns, lot # unknown.Catalog #: 816135024, 3.5mm cort lock scr 24mm ns, lot # unknown qty 3.Catalog #: 110017724, screw t15 lp cort 3.5x24mm ns, lot # unknown.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it was requested but not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00123.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

Reported event was confirmed by review of radiographs.Review of the available records identified the following: plate and screw fixation of the proximal left humeral fracture is present.There is no hardware failure and fracture alignment is anatomic.One of the screws is suboptimally positioned with the screw head extending laterally to the plate.Bone quality is osteopenic.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PRX HUM LO PLT LT 4H 83MM
• Type of Device: TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13306601
• MDR Text Key: 287824805
• Report Number: 0001825034-2022-00125
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00887868134708
• UDI-Public: (01)00887868134708(11)210217(10)RM901P
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K143697
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110030101
• Device Lot Number: RM901P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 70 KG